Documents not associated with any clinical program.  For example, validation documents are needed for systems such as IVRS and EDC applications, but these systems may be used for a number of clinical programs.

Example – Validation documents for an IT system, such as an Electronic Data Capture are Enterprise Level Documents

Documents associated with multiple clinical studies within a program.  For example, the Investigator Brochure generally applies to all ongoing studies for a program, as do various safety documents.

See: Program and Enterprise Documents